A phase IV, open-label, non-randomised, multi-centre study to assess the immunogenicity and safety of a booster dose of Infanrix hexa in healthy infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.
Phase of Trial: Phase IV
Latest Information Update: 30 Sep 2017
At a glance
- Drugs Hib-DTaP-hepatitis B-poliovirus vaccine (Primary) ; Pneumococcal 13-valent CRM197 vaccine conjugate (Primary)
- Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Poliomyelitis; Tetanus
- Focus Pharmacodynamics
- Acronyms DTPA (BOOSTRIX)-049 BST: 048
- Sponsors GlaxoSmithKline
- 10 Jun 2017 Biomarkers information updated
- 17 Apr 2017 Planned primary completion date changed from 22 Apr 2019 to 13 May 2019.
- 24 Jan 2017 Planned number of patients changed from 770 to 680.